Medical Device Daily
PARIS – Implantable cardiac defibrillators (ICDs) are routinely implanted in patients at risk of sudden cardiac death as a result of rhythm disturbances.
So much so that cardiologists' offices are overwhelmed by the required follow-up visits scheduled every 3 months.
Remote monitoring features have since proven to help reduce this burden and throughout the developed western countries, ICDs and the new monitoring technology have seen a rapid adoption.
Except in France.
Where the implantation rate is 140 ICDs per one million population in western countries, penetration in France hovers at 88 ICDs per million.
At the European Society of Cardiology (ESC; Sophia Antipolis, France) two studies designed to yield cost-benefit and resource utilization data for remote monitoring of ICD patients in France were presented, offering new insights into the effectiveness of home monitoring.
Sponsored ICD studies consistently show that remote monitoring is safe, and that they are effective in reducing unnecessary office visits.
But the EVATEL study (EVAluation of TELe follow-up) is the first controlled trial aiming to assess the impact of remote follow up on mortality.
“An important achievement of this study is that it was investigator initiated, included multiple vendors and featured a large patient population,“ said Angelo Auricchio, MD, from Rondazione Cardiocentro Ticino (Lugano, Switzerland) who critiqued the study as a discussant during the ESC Hotline session.
Unfortunately much-anticipated financial data was withheld pending further review by the French government that commissioned the study.
The study was also limited by the caveat that it was technically underpowered, enrolling 1,501 patients rather than the required 1,600.
According to Luc Cheminot, who leads French operations for Biotronik (Berlin), the government funding of the study also came with a strict timeframe forcing the investigators to go forward without waiting for the last 99 patients.
The study also suffered from poor telecommunications with more than 50 patients from the remote-monitoring group converting to the control group due to an inability to transmit data remotely.
There was yet another disappointment for EVATEL investigators in missing the primary endpoint.
EVATEL hypothesized that remote monitoring would affect the rate of major cardiovascular events, defined as all cause death, hospitalization for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.
It did not. There was no difference in survival at one year between the monitored group and the control group.
There were also no statistically significant differences between the two groups for a secondary outcome measures of the time to onset of the first major cardiovascular event and the one-year survival rate.
EVATEL did demonstrate that demonstrate across multiple vendor platforms the safety and efficacy benefits from the remote follow-up of ICD patients.
The one good piece of news was a significant reduction in inappropriate therapy in the remote monitoring group.
Thirty French centers participated in the study and the remote reporting ICDs came from Biotronik, Medtronic (Minneapolis), St. Jude Medical (St. Paul, Minnesota) and Boston Scientific (Natick, Massachusetts).
“The remote follow-up of patients implanted with an ICD seems to be a safe alternative to conventional in-office follow-up,“ said principal investigator Dr Philippe Mabo from the University Hospital of Rennes (France).
“However, for the widespread uptake of this new strategy — at least in France — reimbursement from the healthcare system will be needed,“ he said.
Biotronik's Cheminot said that France currently pays a supplement of €1,000 for an ICD that is capable of home monitoring, requiring in exchange a validation report that the device was actually used and not merely switched on.
Fewer shocks, longer battery life
The ECOST trial (Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology) sponsored from Biotronik investigated the safety, effectiveness, and costs of long-term follow-up over 27 months with Home Monitoring.
Once again, the cost figures have been withheld for review by the French Ministry of Health, apparently still on vacation at the end of August.
Cheminot told Medical Device Daily that the forthcoming results of the cost study will be worth the wait, adding that Biotronik has a unique agreement with the government that will allow the company access to the entire healthcare cost of ICDs per patient, including paramedic interventions, pharmaceutical impacts and monitoring.
A total of 433 patients were followed for 27 months in 43 centers for ECOST with all patients seen in the clinic within the first three months after implantation.
Patients were then randomized to a remote monitoring group or an in-clinic follow-up control group with the remote patients seen in the ambulatory department only once a year unless an anomalous ICD function or an event of clinical concern was reported by remote monitoring.
In the control group, the patients were followed in the ambulatory department at 6-month intervals.
ECOST principal investigator Professor Salem Kacet with the Lille University Hospital Center reported a clear benefit for home monitoring with a 52% reduction of the number of patients with inappropriate shocks and a 72% reduction in the risk of hospitalizations related to inappropriate shocks compared to the control group.
ECOST also demonstrated a 76% reduction in the number of charged shocks with a significant impact on ICD battery longevity.